Biopsy device

ABSTRACT

A biopsy needle device (10) is provided which includes an introducer cannula (20) defining a lumen (25) sized to receive a biopsy needle (11) therethrough and a lateral opening (24) in communication with the lumen (25) adjacent the first end (21) of the cannula (20). The invention also includes a solid tip (30) having an anatomically distal end (31) secured to the first end (21) of the cannula (20) and a proximal end (32) configured to pierce tissue. A ramp (35) is disposed within the cannula (20) at an end (36) of the lateral opening (24) adjacent the first end (21) of the cannula (20). The ramp (35) is inclined toward the lateral opening (24), whereby a biopsy needle (11) will be deflected through the lateral opening (24) as it advances within the lumen (25) and exits the cannula (20). The invention also includes methods of obtaining a biopsy sample using the biopsy device 10 in which a sample is taken, the biopsy needle (11) is retracted, the cannula (20) is rotated and the needle 11 is readvanced to obtain another sample from a different site.

FIELD OF THE INVENTION

The present invention broadly concerns biopsy devices. Morespecifically, the invention concerns biopsy devices which provide safeand efficient coaxial, cofocal and eccentric sampling with only a singlebiopsy device placement.

BACKGROUND OF THE INVENTION

In the practice of diagnostic medicine, it is often necessary ordesirable to perform a biopsy, or to sample selected tissue from aliving patient for medical evaluation. Cytological and histologicalstudies of the biopsy sample can then be performed as an aid to thediagnosis and treatment of disease. Biopsies can be useful in diagnosingand treating various forms of cancer, as well as other diseases in whicha localized area of affected tissue can be identified.

During the biopsy procedure, care is taken to minimize the physicaltrauma inflicted upon the intervening tissues that surround the affectedarea or target tissue and at the same time to protect the practitionerfrom health hazards. One typical biopsy procedure includes inserting ahollow biopsy needle through the intervening tissue into the targettissue to be sampled. The sample tissue is then harvested through theneedle by applying suction through the needle, typically with a syringe.

Other more complicated devices have been developed in an attempt toimprove biopsy procedures and results. Three references, U.S. Pat. No.5,301,684 to Ogirala; U.S. Pat. No. 5,425,376 to Banys et al.; and U.S.Pat. No. 5,224,488 to Neuffer disclose biopsy devices employing lateralopenings. The Ogirala reference shows a cutting edge on a springoperated flap over the lateral opening. The Neuffer device includes atwisted flexible cutting strip contained within the needle. Turning ahandle flexes the strip through the lateral opening. The surgeon thenrotates the device to cut a sample and guide it into the needle. TheBanys patent discloses a biopsy needle attached to a syringe having acannula which is slidable over the needle to alternately expose or coverthe lateral opening. Both the cannula and the lateral opening provide atissue cutting edge. Using the Banys device, the surgeon is required tomaneuver the needle so that the sample is placed within the needle andthe slide the cannula to cover the lateral opening and trap the samplewithin the needle.

Another reference of interest, U.S. Pat. No. 3,001,522 to Silverman,discloses a biopsy device having a pair of resilient arms which extendfrom the end of the device. The arms are disposed at an angle away fromthe axis of the device and are oppositely beveled to urge the arms apartas they are inserted into tissue. The Silverman device does not includea side port or a ramp for exit of a biopsy needle from an introducerdevice.

The prior art biopsy procedures and devices suffer from severaldisadvantages. First, they do not adequately address the need formultiple samplings. It is often desirable to sample the tissuesurrounding a lesion in addition to the lesion itself. Also, needleaspiration biopsies are prone to sampling errors, which necessitatereinsertions of the biopsy needle. Furthermore, none of the known priordevices accommodate the need to reach behind vital organs and structuresbecause they require a straight path to the target.

Current systems require multiple device insertions to sample tissueeccentric to the initial needle placement.

Unfortunately, multiple insertions of the biopsy device increase patientdiscomfort, surgical time and the risk of complications.

Another important consideration in biopsy needle design is that theamount of tissue harvested be sufficient for the types of analysis to bedone. Although major improvements have been made in the sensitivity oftest procedures and apparatus so that smaller samples have becomesufficient for each test, the number of different test procedures andthe importance of having the capability for redundant; or confirmingtesting still necessitates having a suitable sample size. However, thesize of the tissue sample is limited by the size of the opening in thesampling end of known biopsy needles. Where the size of the tissuecollected is inadequate, multiple device insertions will be required.This is often complicated by the difficulty in returning to the exactlocation required as well as the increased trauma to the patient.

Current systems are also limited in that they cause unnecessary traumato the patient. For example, lesions located behind important vascularstructures are difficult to reach without causing damage. Also, pushinga hollow needle through intervening tissues to the target area resultsin the accumulation of unwanted tissue in the needle, which caninterfere with or complicate sample analysis. Finally, the open end of abiopsy needle or the projecting edge of a cutting cannula can tear thesurrounding tissue unnecessarily, increasing trauma to the patient.

Current systems which attempt to address some of these concerns aregenerally complicated spring-operated or multi-component devices.Furthermore, these devices require multiple insertions for samplingeccentric to the initial device placement.

Accordingly, a need has remained for biopsy devices which compensate forsampling errors and accommodate the need for safely and efficientlyobtaining multiple samples with a single device placement.

SUMMARY OF THE INVENTION

Briefly describing one aspect of the invention, there is provided abiopsy device which allows coaxial, cofocal and eccentric sampling witha single biopsy device placement. The invention includes a biopsy needleintroducer device that includes a cannula having a first end and asecond end and defining a lumen. The lumen is sized to receive a biopsyneedle therethrough. The second end of the cannula defines an aperturewhich is sized and configured to receive the biopsy needle. The cannuladefines a lateral opening in communication with the lumen adjacent thefirst end. The lateral opening is sized and configured to allow exit ofan anatomically proximal end of the biopsy needle from the lumen.

The needle introducer devices also include a solid tip having ananatomically distal end secured to the first end of the cannula and aproximal end configured to pierce tissue. In one aspect of theinvention, a ramp is disposed within the cannula at an end of thelateral opening adjacent the first end of the cannula. The ramp isinclined toward the lateral opening whereby the biopsy needle will bedeflected through the lateral opening as it advances within the lumenand exits the cannula.

In one specific aspect of the invention a biopsy needle introducer alsoincludes a hub attached to the second end of the cannula which includesa gripping portion configured to be held when inserting and positioningthe introducer. The hub defines a channel which is in communication withthe aperture.

In one aspect of the invention, the introducer includes means forprotecting the practitioner from inadvertent needle sticks. In aspecific embodiment of the invention, the means includes a flange thatprojects from the hub at a location anatomically distal from thegripping portion. The flange is configured to prevent inadvertent needlesticks when a biopsy needle is inserted into the introducer.

In one specific embodiment, a biopsy needle having a bend adjacent ananatomically proximal end of the needle is provided. The bend deflectsthe proximal end of the needle at an angle away from the longitudinalaxis of the needle.

The invention also includes methods for obtaining a biopsy sample andmethods of making a biopsy device. According to procedures for obtaininga biopsy sample of this invention, a biopsy needle introducer of thisinvention is inserted into a patient at the biopsy site. The biopsyneedle is then inserted into the lumen of the introducer and advanceduntil the proximal end of the biopsy needle projects through the lateralopening at an angle relative to the introducer and into the biopsysample site.

In one aspect of the invention, the biopsy needle is withdrawn from thesample site and the introducer is rotated. The biopsy needle is thenreinserted into the introducer after the introducer is rotated andadvanced to obtain a second biopsy sample from a location eccentric fromthe first biopsy sample site.

In another aspect of the invention, the introducer is rotated with theproximal end of the biopsy needle contained within the lumen. The biopsyneedle is then readvanced to eject the proximal end of the biopsy needlefrom the lumen to obtain a second biopsy sample site from a locationeccentric from the first biopsy sample site.

The invention also provides methods of making biopsy devices. Accordingto the methods of this invention, a hollow cannula defining a lateralopening in communication with the lumen is provided, a hub is attachedto an end of the cannula and the solid tip is secured to the cannula. Inone aspect of the invention, the securing step includes inserting an endof the tip into the first end of the (annula, crimping the cannula ontothe tip for temporary fixation and then welding the tip to the cannula.

It is an object of the invention to provide a biopsy device which allowscoaxial, cofocal and eccentric sampling with a single biopsy deviceplacement. One advantage of the present invention is that it compensatesfor sampling errors without requiring multiple biopsy device placements.Another advantage of this invention is that it accommodates the need forobtaining multiple samples of and around a lesion or target tissuewithout requiring multiple device placements.

Another object of the invention is to provide improved biopsy deviceshaving safety features. The present invention provides means forprotecting practitioners from inadvertent needle sticks. The designs ofthis invention also decrease the trauma to the patient.

Finally, it is an additional object of this invention to provide abiopsy tool which is relatively cost effective to make and relativelyeasy to use. The present invention provides simpler, more efficientoperation which may decrease surgical time and increase accuracy. Thisinvention provides elegant constructs which are less likely tomalfunction than the more complicated spring operated and/ormulti-component devices found in the prior art.

These and other objects, advantages and features are accomplishedaccording to the devices and methods of the following description of thepreferred embodiment of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of a biopsy assembly according to thisinvention.

FIG. 2 is a side view of the needle introducer shown in FIG. 1 with apartial longitudinal section of the proximal end of the introducer.

FIG. 3 is an enlarged side cross-sectional view of the needle introducershown in FIG. 2.

FIG. 4 is an enlarged side cross-sectional view of the biopsy assemblyshown in FIG. 1.

FIG. 5 is an enlarged top cross-sectional view of the proximal end ofthe needle introducer shown in FIG. 2.

FIG. 6 is an end cross-sectional view of the introducer shown in FIG. 2taken along lines 6--6.

FIG. 7 is a side elevational view of the biopsy assembly shown in FIG. 1with a biopsy needle stylet in place.

FIG. 8 is a side elevational view of the introducer of FIG. 2 having anintroducer stylet in place.

FIG. 9 is an enlarged side cross-sectional view of the proximal end ofthe needle introducer shown in FIG. 2 with an introducer stylet inplace.

FIG. 10 is an enlarged side cross-sectional view of the proximal end ofa biopsy assembly incorporating a biopsy needle having a bend.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated devices, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

The present invention provides biopsy devices and methods for obtainingbiopsies and for making biopsy devices. The present invention providesmany benefits such as extremely precise tissue sampling and improvedsafety features. This invention compensates for sampling errors andaccommodates the need for obtaining multiple samples without multipledevice placements by converting peri-target placement into successfulplacement without repositioning the biopsy device. Devices according tothis invention also allow the practitioner to safely reach behindimportant vascular structures to obtain samples from target tissue orlesions. The invention also protects the tissue surrounding the lesionfrom unnecessary trauma. Furthermore, the present invention alsoprovides features which protect the practitioner from inadvertent needlesticks.

A biopsy device assembly 10 in accordance with one preferred embodimentof the present invention is depicted in FIG. 1. Generally, the biopsyassembly 10 includes a biopsy needle 11 and an introducer 15 which ismore clearly shown in FIG. 2. The introducer 15 includes a cannula 20having a first end 21 and a second end 22. The cannula 20 defines alumen 25 which extends between the first end 21 and the second end 22 ofthe cannula 20 as shown more clearly in FIG. 3. A tip 30 which closesthe lumen 25 is disposed at the first end 21 of the cannula 20. Thecannula 20 defines an aperture 23 at the second end 22 of the cannula20. The aperture 23 is in communication with the lumen 25 and is sizedand configured to receive a biopsy needle 11 for passage into the lumen.

The cannula 20 also defines a lateral opening 24 which is incommunication with the lumen 25 The lateral opening 24 is preferablyadjacent the first end 21 of the cannula 20. The lateral opening 24 issized and configured to allow exit of a biopsy needle from the cannulaas it is advanced through the lumen 25.

The lateral opening 24 allows the practitioner to sample multiple areaswithin a sampling zone defined around the introducer 15. The introducer15 can be rotated so that the lateral opening 24 will be exposed todifferent areas within the sampling zone, so that a biopsy needle 11 canbe directed into these different areas. In this way, a single placementof the biopsy device, or introducer, provides cofocal and eccentricsampling as well as coaxial sampling. Typical biopsy needles allowcoaxial sampling by varying the depth of the needle placement butrequire additional device placements for cofocal or eccentric sampling.This invention, on the other hand, allows the practitioner to return tothe precise location within the target tissue with a second biopsyneedle by leaving the introducer in place. As shown in FIGS. 3-5, theintroducer 15 preferably includes a ramp 35 disposed within the cannula20 at an end 36 of the lateral opening 24 adjacent the first end 21 ofthe cannula 20. The ramp 35 is inclined toward the lateral opening 24.In the operation of the biopsy assembly 10, a biopsy needle 11 will bedeflected through the lateral opening 24 as it is advanced through thelumen 25 and exits the cannula 20. The ramp 35 provides controlled exitof the biopsy needle 11. The slope of the ramp may be altered to obtaina desired angle of deflection of the needle 11 as it exits the lateralopening 24.

In a preferred embodiment, the solid tip 30 is preferably a separatecomponent which is secured to the first end 21 of the cannula 20 asshown in FIGS. 2-5. The anatomically distal end 31 of the tip 30 can besecured to the cannula 20 using any suitable means. The tip 30 includesa shaft 33 extending between the distal end 31 and the proximal end 32.The tip 30 also includes an anatomically proximal end 32 which isconfigured to pierce tissue. The proximal end 32 preferably extendsbeyond the first end 21 of the cannula 20. The solid tip 30 can beprovided in any length which suits the particular application. Varyingthe length of the solid tip varies the distance from the proximal end 32to the lateral opening 24 and from the proximal end 32 of the tip 30 tothe proximal end 12 of the needle 11.

It is contemplated that the proximal end 32 has a configuration that issuited for the particular tissue to be sampled. For example, the tip maybe beveled. In one embodiment, the tip has a trocar geometry. Themultiple bevels of the trocar tip are useful in combination with ahigher gage cannula for use in denser tissue. In one specificembodiment, a trocar tip is used with an 18 gage cannula. A single bevelis useful in combination with a thinner gage cannula for applicationswhich require steering or for use in less dense tissue. For example,sampling lymph node tissue generally requires a smaller gage cannula,and consequently is better served by a single bevel tip.

Turning back to the distal end 31 of the tip 30, this end is preferablysloped to form the ramp 35. In a specific embodiment, as shown moreclearly in FIG. 3, a portion 34 of the shaft 33 extends slightly intothe lateral opening 24. This provides a smooth exit of the biopsy needle11 through the lateral opening 24 and prevents catching of the needle 11on the cannula 20 near edge of the lateral opening 24.

Preferably, the distal end 31 of the tip 30 has an outer diameter D_(t)which is smaller than an inner diameter D_(c) of the first end 21 of thecannula 20. The distal end 31 of the tip 30 is then at least partiallydisposed within the lumen 25 at the first end of the cannula 20. The tip30 can be secured to the cannula 20 by an interference fit. Preferably,the cannula 20 is crimped onto the solid tip 30 to hold the tip in thedesired position within the cannula while the tip is laser welded to thecannula. It is contemplated that the cannula 20 can also be secured tothe tip 30 by any other suitable means including an adhesive.

In a preferred embodiment, the invention includes a hub 40 attached tothe second end 22 of the cannula 20 as depicted in FIG. 2. Referringalso to FIG. 6, hub 40 defines a channel 45 for delivering a biopsyneedle to the cannula 20. The channel 45 includes a first end 46 and asecond end 47. The first end 46 of the channel 45 surrounds the secondend 22 of the cannula 20 and is in communication with the aperture 23.The channel 45 of the hub 40 is preferably funnel shaped as shown inFIGS. 2 and 6. The first end 46 of the channel 45 has an interior radiusR_(i) that is smaller than the interior radius R₂ of the second end 47of the channel 45. The channel 45 tapers from the second end 47 of thechannel 45 to the first end 46 of the channel 45 to guide a biopsyneedle from the hub 40 to the lumen 25 of the cannula 20.

The hub 40 also preferably includes a fitting end 43 adjacent the secondend of the channel. The fitting end 43 is configured for engagement witha starlet or a syringe. It is contemplated that the fitting end 43 willbe of any suitable configuration including, but not limited to, a Luer®fitting.

The hub 40 preferably includes a gripping portion 41 as shown in FIG. 2.The gripping portion 41 is configured to be held by the practitionerduring insertion and positioning of the introducer 19. In oneembodiment, the gripping portion 41 of the hub 40 includes a flattenedportion 42 which provides the practitioner with a more stable grip onthe hub 40 as depicted in FIG. 7. The flattened portion 42 also providesa tactile reference point for the location of the lateral opening 24.Preferably the flattened portion 42 is oriented on the same side of thecannula 20 as the lateral opening 24; however, any orientation iscontemplated as long as it indicates the relative position of thelateral opening 24.

Referring again to FIG. 1, the cannula 20 of the introducer 19preferably includes a plurality of depth markings 27 located in spacedrelation along the cannula 20. These markings are preferably arranged ingroups of five to give a ready visual indication of the depth ofinsertion of the cannula 20. Where the cannula 20 is composed oftitanium, at least some of the depth markings 27 are preferablyradiographic.

The present invention provides means for protecting the practitionerfrom health risks. In one preferred embodiment, the introducer 15includes a flange 50 projecting from the hub 40 at a locationanatomically distal from the gripping portion 41. The flange 50 isconfigured to prevent inadvertent needle sticks when the practitioner isholding the hub 40 during insertion of a biopsy needle into theintroducer. This is particularly valuable when a biopsy needle isreinserted into the introducer. In light of the attention given to bloodborne diseases in recent years, the need for such features is selfevident. Any size or shape flange is contemplated which will protect thepractitioner's fingers from needle sticks. Preferably, the flange iscircular and extends from the hub at least 15 mm. Most preferably, thecircular flange includes a flattened portion which prevents rolling ofthe device when it is placed on a flat surface. Alternatively, theflange can be hexagonal or octagonal providing many flat sides.

Referring now to FIGS. 8 and 9, the invention contemplates an introducerstylet 55 which includes a shaft 57 and a grip 60. The shaft 57 is sizedto be received within the lumen 25.

Preferably, the introducer stylet 55 has a length sufficient to blockthe lateral opening 24 when the introducer stylet 55 is received withinthe lumen 25. Most: preferably, the introducer stylet 55 has an angledend 58 which is configured to mate with the ramp 35 when the introducerstylet 55 is received within the cannula 20. Blocking the lateralopening 24 is important to reduce trauma to the surrounding tissue andpreserve the integrity of the sample by preventing tissue from enteringthe lateral opening 24 as the introducer is guided into the patient. Theintroducer stylet 55 also provides stiffness to the introducer cannula20 to facilitate insertion.

The biopsy assembly 10 shown in FIG. 1 includes a hollow biopsy needle11 having an anatomically proximal end 12 and a distal end (not shown).The biopsy needle 11 is sized and configured to be movably, rotatablyand coaxially received within the lumen 25. The proximal end 12 of thebiopsy needle 11 is sized and configured to exit from the lumen 25through the lateral opening 24 as shown in FIG. 4. The biopsy needle 11preferably includes an edge 13 which is configured to pierce tissue toobtain a biopsy sample when the biopsy needle 11 is advanced intotissue.

Any suitable biopsy needle is contemplated. Standard hollow biopsyneedles are preferred, such as the Mengehni type. The proximal end 12 ofbiopsy needle 11 includes an edge or tip that may be of any suitableconfiguration. As shown in FIG. 4 the edge 14 may be blunt. As shown inFIG. 10, the edge 14 may be beveled. The biopsy needle may furtherinclude a needle hub which may include a channel 18 which is preferablyfunnel shaped as described above for the introducer hub 40. The biopsyneedle hub 19 may also include a flattened portion 19A which provides agripping and reference function as described above.

In one embodiment the biopsy needle 11 includes a bend 16 adjacent theproximal end 12 of the needle 11 as shown in FIG. 10. The bend 16deflects the proximal end 12 of the needle 11 at an angle α away from alongitudinal axis 11 of the needle 11 when the bend 17 extends outsidethe cannula 20. The bend 16 increases the diameter of the sampling zoneof the tissue. Multiple samples in a single plane can also be obtainedby providing needles having bends of varying angles and curves. Theangle α is preferably between 5° and 30°. The most preferred angle αbeing about 15°. Where the needle 11 is bent, the ramp 35 may include aconcavely curved surface to facilitate smooth exit of the needle 11through the lateral opening 24.

As shown in FIG. 7, the invention also contemplates a biopsy needlestylet 70. The biopsy stylet 70 facilitates guiding the biopsy needle 11through the lateral opening 24. The biopsy needle stylet 70 includes ahandle 71 and a shaft 75. The handle 71 may include a locking nub 72which mates with a notch (not shown) on the biopsy needle hub 17 forlocking the biopsy stylet into place. The shaft 75 of the biopsy stylet70 is sized and configured to be received within the biopsy needle 11.Preferably, the biopsy needle stylet 70 has a penetrating point 76 thatextends away from the proximal end of the biopsy needle 11 when thebiopsy needle stylet 70 is inserted into the biopsy needle 11. Thepenetrating point 76 aids collection of the sample by piercing thetissue before the tissue is collected within the needle 11. Any suitablyshaped penetrating point is contemplated. For example, penetrating point76 may be rounded or may have a trocar geometry.

Methods of obtaining a biopsy sample are also contemplated by thepresent invention. Preferably, the methods of this invention arepracticed in combination with an imaging study to determine theappropriate needle path to the biopsy sample site. The methods includeproviding a biopsy introducer of the present invention and inserting thebiopsy introducer into the patient at the biopsy sample site usingstandard surgical procedures. Preferably, the methods of this inventionalso include inserting an introducer assembly which includes anintroducer stylet inserted into the cannula. The introducer stylet issized to be received within the lumen and preferably has a length suchthat it will block; the lateral opening when the introducer stylet isreceived within the lumen to prevent tissue from entering the lateralopening when the cannula is introduced into the patient. The introducerstylet also provides stiffness to the introducer cannula to facilitateinserting the introducer into tissue. Once the introducer assembly isinserted, the practitioner removes the introducer stylet.

Once the introducer is in place, the invention includes inserting abiopsy needle having an anatomically proximal end and a distal endthrough the aperture and into the lumen of the introducer, advancing thebiopsy needle through the lumen so that the proximal end of the biopsyneedle projects through the lateral opening at an angle relative to theintroducer and into a first biopsy sample site to obtain a first biopsysample, and then withdrawing the proximal end of the biopsy needle fromthe first biopsy sample site and into the lumen of the introducer. As iswell known in the art, a locking member L such as the one shown in FIG.1 can be used to control the depth of the introducer.

The biopsy needle may be provided with a biopsy needle stylet insertedinto the lumen of the hollow biopsy needle. The practitioner will removethe biopsy needle stylet after the biopsy needle has been inserted intothe lumen of the introducer. The biopsy needle stylet provides stiffnessto the hollow biopsy needle which facilitates guiding the needle throughthe lateral opening. Preferably, the stylet includes a penetrating tipwhich pierces the subject tissue as the needle-stylet assembly isadvanced through the lumen of the introducer and into the tissue.

After the stylet is removed, a sample is collected. The sample ispreferably collected by applying suction to the biopsy needle to draw afirst biopsy sample into the biopsy needle through its proximal end.Suction may be applied in any suitable manner. Preferably a syringe willbe attached to the Luer fitting on the hub of the introducer to draw avacuum. Most preferably, the collecting step will also includereciprocating the biopsy needle within the lumen while applying suctionso that the needle edge can help excise the tissue.

This invention contemplates that: multiple samples which are cofocal,coaxial and eccentric to the original biopsy sample can be taken in thismanner with only a single placement of the biopsy device. The tissuethat is available to be sampled can be increased by rotating theintroducer to change the exposure of the lateral opening or by alteringthe shape of the biopsy needle.

In one embodiment of the invention, the methods include removing thebiopsy needle from the introducer after withdrawing the biopsy needlefrom the biopsy site, clearing the sample from the biopsy needle,rotating the introducer, reinserting the biopsy needle through theaperture and into the lumen after clearing the sample, further advancingthe biopsy device to eject the proximal end of the biopsy needle fromthe lumen through the lateral opening at the same angle relative to theintroducer to obtain a second biopsy sample from a location eccentricfrom the first biopsy sample, and withdrawing the proximal end of thebiopsy needle from the biopsy sample site into the lumen of theintroducer. Although the biopsy needle is removed from the sample site,the introducer is left in place. Therefore, the practitioner is able toinsert the needle in a precise location relative to the initial samplesite.

Alternatively, the methods may include rotating the introducer with theproximal end of the biopsy needle contained within the lumen and thenfurther advancing the biopsy device to eject the proximal end of thebiopsy needle from the lumen through the lateral opening. A secondbiopsy sample may be obtained from a location eccentric from the firstbiopsy sample. Additional samples may be taken which are cofocal,coaxial and eccentric from the original sample can be taken withoutclearing the sample from the needle.

The methods of this invention 31so contemplate that the sample siteaccessible to the single biopsy device placement can be broadened byadjusting the angle by which the biopsy needle is deflected from thecannula. This may be accomplished by either providing a second biopsyneedle having a bend adjacent an anatomically proximal end of theneedle, the bend deflecting the proximal end of the second needle at anangle away from a longitudinal axis of the second needle or by bendingthe first biopsy needle in a similar manner. The bent needle issimilarly inserted through the aperture and into the lumen and advancedso that the proximal end projects through the lateral opening at adifferent angle relative to the introducer to obtain a second biopsysample. For example, the second biopsy sample site may be located in aplane defined by the first biopsy sample site and the introducer or maybe eccentric to the first site. The invention contemplates rotating theintroducer and bending the needle so that the desired tissue locationmay be reached.

This invention also provides methods of making a biopsy devices. Themethods include: attaching a hub defining a channel to a hollow cannulaand securing an anatomically distal end of a solid tip to the first endof the cannula. The hub is engaged to the cannula by conventionaltechniques such as insert molding. Preferably, the distal end of the tiphas an outer diameter smaller than an inner diameter of the first end ofthe cannula and the securing includes inserting the distal end of saidtip into the first end of the cannula. Preferably, the cannula has avery thin wall. In one embodiment, the securing includes employing amechanical or interference fit, such as crimping the cannula onto thetip. The securing also preferably includes welding. Most preferably, themethods include laser welding or brazing the tip and the cannula afterthe cannula has been crimped into place on the tip. In a preferredembodiment, the cannula is crimped onto the tip so that the ramp formedby the tip is located to ensure that a biopsy needle advancing throughthe lumen does not catch on the portion of the cannula forming thelateral opening. Any methods which provide a smooth transition betweenthe tip and the cannula are contemplated. A smooth transition reducestrauma to tissue during insertion of the device. Any other suitablemethods of securing the tip to the cannula are contemplated includingapplying an adhesive.

The devices of the present invention may be provided in any suitablesize and in any suitable material. For example, in one embodiment, thecomponents are made from 300 series stainless steel. Alternatively, someof the components may be composed of titanium or Inconel. The size ofthe components are dictated by the type and location of the tissue to besampled.

The present invention includes devices and methods that provideextremely precise biopsy sampling without requiring extremely precisebiopsy device placement. The invention compensates for peri-lesionneedle placement and accommodates the need for obtaining multiplesamples of and around a lesion. The invention also provides safeguardsfor the practitioner and the patient.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiments have been shown and described and thatall changes and modifications that come within the spirit of theinvention are desired to be protected.

What is claimed is:
 1. A biopsy needle introducer, comprising:a cannulahaving a first end and a second end and defining a lumen therebetween,the lumen sized to receive a biopsy needle therethrough; the second endof the cannula defining an aperture, the aperture sized and configuredto receive a biopsy needle for passage into the lumen; said cannuladefining a lateral opening in communication with the lumen adjacent saidfirst end, the lateral opening sized and configured to allow exit of ananatomically proximal end of the biopsy needle from the lumen; and asolid tip having an anatomically distal end secured to the first end ofsaid cannula and a proximal end configured to pierce tissue, wherein thedistal end of said tip has an outer diameter smaller than an innerdiameter of the first end of the cannula and the distal end of said tipis at least partially disposed within said lumen at the first end of thecannula.
 2. The biopsy needle introducer of claim 1 wherein the tip issecured to the cannula by an interference fit.
 3. The biopsy needleintroducer of claim 2, wherein said said cannula is crimped onto saidsolid tip.
 4. The biopsy needle introducer of claim 1 wherein the tip issecured to the cannula by welding.
 5. The biopsy needle device of claim1 wherein the tip is secured to the cannula with an adhesive.
 6. Abiopsy needle introducer, comprising:a cannula having a first end and asecond end and defining a lumen therebetween, the lumen sized to receivea biopsy needle therethrough; the second end of the cannula defining anaperture, the aperture sized and configured to receive a biopsy needlefor passage into the lumen; said cannula defining a lateral opening incommunication with the lumen adjacent said first end, the lateralopening sized and configured to allow exit of an anatomically proximalend of the biopsy needle from the lumen; a solid tip having ananatomically distal end secured to the first end of said cannula and aproximal end configured to pierce tissue; and an introducer stylet sizedto be received within the lumen, the introducer stylet having a lengthsufficient to block the lateral opening when the introducer stylet isreceived within the lumen.
 7. The biopsy needle introducer of claim 6,wherein the distal end of the tip is sloped to form a ramp adjacent andinclined toward the lateral opening, whereby a biopsy needle will bedeflected through the lateral opening as it exits the cannula andwherein the introducer stylet has an angled end configured to mate withthe ramp when the introducer stylet is received in the cannula.
 8. Thebiopsy needle introducer of claim 1, further comprising a hub attachedto the second end of the cannula, said hub defining a channel having afirst end and a second end, the first end in communication with theaperture for delivering a biopsy needle to the lumen.
 9. The introducerof claim 8 wherein said hub is funnel shaped, the first end of thechannel having an interior radius that is smaller than an interiorradius of the second end of the channel, the channel tapering from thesecond end of the channel to the first end of the channel to guide abiopsy needle from the hub to the lumen.
 10. A biopsy device,comprising: an introducer includinga cannula having a first end and asecond end and defining a lumen therebetween, a tip disposed at thefirst end of the cannula and closing the lumen, the cannula defining anaperture at the second end of the cannula, the aperture sized andconfigured to receive a biopsy needle, andsaid cannula defining alateral opening in communication with the lumen adjacent said first end,the lateral opening sized and configured to allow exit of a biopsyneedle from the lumen; and a hollow biopsy needle having an anatomicallyproximal end and a distal end, said needle sized and configured to bemovably and rotatably received within the lumen, the proximal end sizedand configured to exit from said lumen through the lateral opening andhaving an edge to pierce tissue to obtain a biopsy sample when thebiopsy needle is advanced into the tissue.
 11. The biopsy device ofclaim 10, further comprising a ramp disposed within said cannula at anend of the lateral opening adjacent the first end of the cannula, saidramp being inclined toward the lateral opening, whereby said biopsyneedle will be deflected through the lateral opening as it advanceswithin the lumen and exits the cannula.
 12. The biopsy device of claim11, further comprising a hub attached to said second end, said hubincluding a gripping portion configured to be held when inserting andpositioning the introducer, said hub defining a channel having a firstend and a second end, the first end in communication with the aperturefor delivering a biopsy needle to the lumen.
 13. The biopsy device ofclaim 12 wherein said hub is funnel shaped, the first end of the channelhaving an interior radius that is smaller than an interior radius of thesecond end of the channel, the channel tapering from the second end ofthe channel to the first end of the channel to guide a biopsy needlefrom the hub to the lumen.
 14. The biopsy device of claim 11, furthercomprising an introducer stylet sized to be received within the lumen,the introducer stylet having a length sufficient to block the lateralopening when the introducer stylet is received within the lumen.
 15. Thebiopsy device of claim 14, wherein said introducer stylet has an angledend configured to mate with said ramp when said introducer stylet isreceived in the cannula.
 16. The biopsy device of claim 11 wherein saidneedle includes a bend adjacent the proximal end of said needle, thebend deflecting the proximal end of said needle at an angle away from alongitudinal axis of said needle when said bend extends outside saidcannula.
 17. The biopsy device of claim 11, further comprising a biopsyneedle stylet sized and configured to be received within said biopsyneedle.
 18. The biopsy device of claim 17 wherein the biopsy needlestylet has a penetrating point that extends from the proximal end of thebiopsy needle when the biopsy stylet is inserted into said biopsyneedle.
 19. The biopsy device of claim 18 wherein the penetrating pointis rounded.
 20. The biopsy device of claim 18 wherein the penetratingpoint has a trocar geometry.
 21. A biopsy needle introducer,comprising:a cannula having a first end and a second end and defining alumen therebetween, the lumen sized to receive a biopsy needletherethrough; the second end of the cannula defining an aperture, theaperture sized and configured to receive a biopsy needle; a hub attachedto the second end of the cannula, said hub including a gripping portionconfigured to be held when inserting and positioning the introducer,said hub defining a channel having a first end and a second end, thefirst end of the channel in communication with the aperture fordelivering a biopsy needle to the cannula; and flange means projectingfrom said hub at a location anatomically distal from the grippingportion for preventing inadvertent needle sticks when a biopsy needle isinserted into the introducer.
 22. The introducer of claim 21 whereinsaid hub is funnel shaped, the first end of the channel having aninterior radius that is smaller than an interior radius of the secondend of the channel, the channel tapering from the second end of thechannel to the first end of the channel to guide a biopsy needle fromthe hub to the lumen.
 23. The biopsy needle of claim 21 furthercomprising a plurality of depth markings located in spaced relation onsaid cannula.
 24. The biopsy needle of claim 23 wherein said markingsare radiographic.
 25. The introducer of claim 21, further comprising:aclosed tip disposed at the first end of the cannula; and said cannuladefining a lateral opening in communication with the lumen, the lateralopening sized and configured to allow exit of an anatomically proximalend of the biopsy needle from the lumen.
 26. The biopsy needleintroducer of claim 25, further comprising a ramp disposed within saidcannula at an end of the lateral opening adjacent said first end of saidcannula, the ramp being inclined toward the lateral opening, whereby abiopsy needle will be deflected through the lateral opening as it exitsthe cannula.
 27. The introducer of claim 26 wherein said hub is funnelshaped, the first end of the channel having an interior radius that issmaller than an interior radius of the second end of the channel, thechannel tapering from the second end of the channel to the first end ofthe channel to guide a biopsy needle from the hub to the lumen.
 28. Thebiopsy needle of claim 27 further comprising a plurality of depthmarkings located in spaced relation on said cannula.
 29. The biopsyneedle of claim 28 wherein said markings are radiographic.
 30. A methodof obtaining a biopsy sample, comprising: providing a biopsy introducer,said introducer havinga cannula having a first end and a second end anddefining a lumen therebetween; a tip disposed at the first end of thecannula and closing the lumen at the first end; the lumen having anaperture at the second end of the cannula, the aperture sized andconfigured to receive a biopsy needle; the cannula defining a lateralopening in communication with the lumen, the lateral opening sized andconfigured to allow exit of a biopsy needle from the lumen; and a rampdisposed within said cannula at an end of the lateral opening adjacentthe first end of the cannula, the ramp being inclined toward the lateralopening, whereby a biopsy needle will be deflected through the lateralopening as it exits the cannula; inserting the introducer into thepatient at the biopsy site; inserting a biopsy needle having ananatomically proximal end and a distal end through the aperture and intothe lumen; advancing the biopsy needle through the lumen so that theproximal end of the biopsy needle projects through the lateral openingat an angle relative to the introducer and into a first biopsy samplesite to obtain a first biopsy sample; and withdrawing the proximal endof the biopsy needle from the first biopsy sample site and into thelumen of the introducer.
 31. The method of claim 30 further comprisingperforming an imaging study to determine an appropriate needle path tothe biopsy sample site.
 32. The method of claim 30, furthercomprising:inserting an introducer stylet into the cannula beforeinserting the introducer into the patient, the introducer stylet sizedto be received within the lumen, the introducer stylet having a lengthsuch that it will block the lateral opening when the introducer styletis received within the lumen to prevent tissue from entering the lateralopening when the cannula is introduced into the patient; and removingthe introducer stylet before inserting the biopsy needle into theintroducer.
 33. The method of claim 30, further comprising:applyingsuction to the biopsy needle to draw a first biopsy sample into thebiopsy needle before withdrawing the biopsy needle from the first samplesite.
 34. The method of claim 33, further comprising reciprocating thebiopsy needle within the lumen while applying suction.
 35. The method ofclaim 33 further comprising:inserting a biopsy needle stylet into thebiopsy needle before inserting the biopsy needle into the lumen; andremoving the biopsy needle stylet before applying suction to the biopsyneedle.
 36. The method of claim 30, further comprising:removing thebiopsy needle from the introducer after withdrawing the biopsy needlefrom the biopsy site; clearing the sample from the biopsy needle;rotating the introducer; reinserting the biopsy needle through theaperture and into the lumen after clearing the sample; further advancingthe biopsy device to eject the proximal end of the biopsy needle fromthe lumen through the lateral opening at the same angle relative to theintroducer to obtain a second biopsy sample from a location eccentricfrom the first biopsy sample; and withdrawing the proximal end of thebiopsy needle from the biopsy sample site into the lumen of theintroducer.
 37. The method of claim 30, further comprising:rotating theintroducer with the proximal end of the biopsy needle contained withinthe lumen and further advancing the biopsy device to eject the proximalend of the biopsy needle from the lumen through the lateral opening atthe same angle relative to the introducer to obtain a second biopsysample from a location eccentric from the first biopsy sample; andwithdrawing the proximal end of the biopsy needle from the biopsy samplesite into the lumen of the introducer.
 38. The method of claim 30,further comprising:withdrawing the biopsy needle from the lumen;providing a second biopsy needle having a bend adjacent an anatomicallyproximal end of the needle, the bend deflecting the proximal end of thesecond needle at an angle away from a longitudinal axis of the secondneedle; inserting the second needle through the aperture and into thelumen; advancing the second needle so that the proximal end projectsthrough the lateral opening at a different angle relative to theintroducer to obtain a second biopsy sample.
 39. The method of claim 38wherein the second biopsy sample site is located in a plane defined bythe first biopsy sample site and the introducer.
 40. A method of makinga biopsy device, comprising:providing a hollow cannula defining a lumensized to receive a biopsy needle and a lateral opening at a first end ofthe cannula, the lateral opening in communication with the lumen, thelateral opening sized and configured to allow exit of an anatomicallyproximal end of the biopsy needle from the lumen; attaching a hub to thesecond end of the cannula, the hub defining a channel in communicationwith the lumen; and securing an anatomically distal end of a solid tipto the first end of the cannula, the tip having a proximal endconfigured to pierce tissue, the distal end of the tip being sloped toform a ramp adjacent to and inclined proximally toward said lateralopening, whereby a biopsy needle will be deflected as it advancesthrough the lumen and exits the cannula through the lateral opening. 41.The method of claim 40 wherein the distal end of the tip has an outerdiameter smaller than an inner diameter of the first end of the cannulaand the securing includes inserting the distal end of said tip into thefirst end of the cannula.
 42. The method of claim 41 wherein thesecuring includes employing an interference fit.
 43. The method of claim41 wherein the securing includes welding.
 44. The method of claim 41wherein the securing includes applying an adhesive.